Medical Devices – South Korea - update on UDI developments

The Korean FDA confirmed the timeframe for UDI in Korea and mentioned that the 3-issuing agencies accredited by the US FDA will be selected for Korea. GS1 standards are the only UDI standard used by Korean manufacturers, but HIBCC and ICCBBA will also be allowed to facilitate implementation by multinational companies.

A draft rule will be published between February and April 2017. The national UDI DataBase and traceability system should be set-up from March to October. A pilot will then start after October until January 2018. Implementation by Class will start as from January 2019.